Overview
Quality Control Jobs in Niles, IL at Multi-Color Corporation
QC/Production Associate II
Title | QC/Production Associate II
Department | Network Operations
Reports To | Facility Manager
Overview
The QC/Production Associate II will operate and maintain the radiosynthesizers for the production of drug product, as well as operate and maintain analytical equipment for the quality control of drug product. They will also aid the Facility Manager in training of QC/Production personnel as applicable.
Essential Duties and Responsibilities
Perform FDG, NaF, and 1-2 other products’ synthesis according to SOFIE Standard Operating Procedures (SOPs):
Ensure all materials/reagents are accepted according to SOPs and within expiry
Ensure all equipment is appropriately qualified prior to use
Operate the synthesis unit according to SOPs
Operate a semi-preparative HPLC system
Learn the basic operational principles of the synthesis unit and semi-preparative HPLC and perform routine maintenance of the synthesis unit and semi-preparative HPLC
Perform FDG, NaF, and 1-2 other products’ quality control (QC) processes according to SOPs:
Perform basic maintenance and qualification of QC equipment
Ensure all equipment is appropriately calibrated and qualified prior to use
Operate the QC equipment according to SOPs
Prepare reagents for QC
Perform troubleshooting of QC equipment under advisement of Corporate QC Department or others
Ensure completion of applicable cGMP documentation.
Perform inventory management:
Maintain production/QC/cleaning supply levels as appropriate
Perform inventory reporting
Perform material acceptance according to SOPs
Communicate with local and Network support resources to troubleshoot equipment, production, or QC issues.
Perform basic computer-controlled cyclotron operations for FDG, NaF, and 1-2 other products’ production under the advisement of site Cyclotron and Facility Engineer.
Maintain a clean and safe working environment.
Perform radiation safety duties according to SOFIE’s Corporate Radiation Compliance Program and site licensing requirements.
Maintain all qualification and validation requirements for entering ISO classified area.
Clean classified and non-classified areas according to SOPs.
Perform environmental monitoring of classified areas according to SOPs.
Report manufacturing metrics into data repository as required.
Complete cGMP documents as required and assist site and corporate Quality Assurance including, but not limited to:
Investigations
Corrective and Preventative Actions
Deviations
Out of Specifications
No or Atypical Yields
Manufacturing and QC Records
Logbooks
Assist with training of QC/Production Associate I personnel.
Attend internal meetings as required.
Other assigned duties as required.
Qualifications
High school diploma required; associates degree in chemistry, engineering, or natural sciences preferred.
2-years’ experience in radiopharmaceutical manufacturing and quality control required.
Technical experience with computer-controlled automation required.
Efficient in the use of MS Office Suite required.
Ability to work various shifts and weekends required.
Ability to be detail-oriented, accountable, patient, organized, and work in a team environment required.
Ability to communicate professionally with colleagues and customers, have excellent attention to detail, and be dependable and responsible in a fast-paced, highly technical environment required.
Ability to lift ~50 lbs. required.
Up to 10% travel required.
Job Type: Full-time
Benefits:
401(k)
401(k) matching
Dental insurance
Flexible spending account
Health insurance
Life insurance
Paid time off
Parental leave
Tuition reimbursement
Vision insurance
Schedule:
Day shift
Night shift
Weekends as needed
Work Location: In person
Show more
Title: Quality Control
Company: Multi-Color Corporation
Location: Niles, IL
